Quality Control Associate Scientist

Huvepharma, Inc.; Lincoln (NE); On-site; USD 55,000 - 75,000; Full time

Job summary

Huvepharma, Inc. seeks a Quality Control Laboratory support role to assist in day-to-day testing of in-process and final products and to execute protocols for stability and method transfer.

The candidate will work under supervision and contribute to safety, accuracy, and regulatory documentation, with opportunities to mentor junior staff and participate in process improvements.

Qualifications

• Associate degree required; Bachelor’s preferred.
• 3–5 years (Bachelor’s) or 5–8 years (Associate) of technical experience in pharma or related industry.

Responsibilities

• Read and follow SOPs and safety documents.
• Handle biological agents and chemicals safely.
• Work independently and in a team.
• Adapt to changing priorities.
• Meet established timelines.
• Maintain notebooks and regulatory-compliant docs.
• Assist with media/reagent prep and inventory.
• Calibrate and maintain lab equipment.
• Maintain mammalian cell cultures and growth promotion testing.
• Perform in-process and final product testing per requirements.
• Prepare and qualify assay controls under supervision.
• Execute laboratory protocols under supervision.
• Train/mentor lab personnel as assigned.
• Review regulatory documents for accuracy and compliance.
• Suggest process improvements for safety and efficiency.
• Communicate with colleagues at all levels.
• May require weekend/holiday work.

Skills

Attention to detail

Organizational skills

Time management

Verbal communication

Written communication

Electronic communication

Team collaboration

Education

Associate degree in Microbiology/ Biology/ Immunology or life science

Tools

Microsoft Office

Database management

Job description

General Description:

This position is responsible for supporting day-to-day operations within the Quality Control laboratory, with primary focus on in-process and final product testing. This position will also assist in the execution of laboratory protocols for product stability, method transfer, and reagent qualification studies.

Qualifications:

• Associate degree in Microbiology, Biology, Immunology, or related life science required; Bachelor’s degree preferred
• 3-5 years (Bachelor’s degree) or 5-8 years (Associate degree) of technical experience in the pharmaceutical or related industry required
• Previous Quality Control or equivalent laboratory experience working in a USDA- or FDA-regulated environment preferred
• Knowledge and understanding of applicable USDA regulations and GMPs preferred
• Experience with aseptic technique preferred
• Excellent attention to detail
• Strong organizational and time management skills
• Excellent verbal, written, and electronic communication skills
• Competent computer skills utilizing Microsoft Office (e.g., Word, Excel, Outlook) and database management
• Knowledgeable about biosafety requirements and aseptic technique

Job Responsibilities:

• Read and follow standard operating procedures and safety documents
• Handle biological agents and chemicals safely
• Effectively work independently and as part of a team
• Must adapt well to changing priorities
• Must consistently meet established timelines
• Perform concurrent documentation and maintain accurate laboratory notebooks to ensure compliance with regulatory requirements and company quality systems
• Assist with media/reagent preparation, laboratory cleaning, inventory maintenance, and daily equipment monitoring
• Assist with the calibration and maintenance of laboratory equipment
• Maintain mammalian cell cultures and/or perform growth promotion testing of media
• Perform in-process and final product testing in accordance with internal and external requirements, such as virus titration, bacterial enumeration, or sterility testing
• Under supervision, prepare and qualify new assay controls
• Under supervision, execute laboratory protocols
• Perform limited animal care and husbandry related to product testing
• Perform routine laboratory investigations, complete Corrective/Preventative Actions as assigned
• Effectively train and/or mentor laboratory personnel as assigned
• Review regulatory documents for accuracy and verify compliance with established procedures
• Recommend initiatives to improve processes, cost effectiveness, efficiency, safety, and compliance
• Effectively communicate with colleagues at all levels
• This position may require periodic weekend and/or holiday work